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Effect of Symbicort on Sleep Quality in Patients With Emphysema

Primary Purpose

Emphysema, Poor Sleep Quality

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide/formoterol
Placebo
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Emphysema, COPD, Sleep

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe emphysema (GOLD stages 2 and 3)

Exclusion Criteria:

  • Use of supplemental oxygen,
  • A recent COPD exacerbation within the past 4 weeks.
  • A previous diagnosis of obstructive sleep apnea
  • A known urinary outflow obstruction,
  • Glaucoma
  • History of an allergic reaction to one of the study medications.

Sites / Locations

  • Temple Lung Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

budesonide/formoterol

Placebo

Arm Description

budesonide/formoterol 160/4.5 mcg (Symbicort)

Symbicort placebo

Outcomes

Primary Outcome Measures

The primary outcome is the objective assessment of sleep quality.
Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.

Secondary Outcome Measures

Secondary outcome includes assessment of nocturnal oxygenation.
Nocturnal oxygenation will be measured by pulse oximetry.
Secondary outcome is the subjective assessment of sleep quality.
Quality of life will be assessed by SF-36 and SGRQ-C scores.
Secondary outcome includes assessment respiratory mechanics/function.
Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
Secondary outcome includes assessment of overall quality of life.
Quality of life will be assessed by SF(short form)-36 and SGRQ-C(ST George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease patients)scores.

Full Information

First Posted
April 23, 2012
Last Updated
December 6, 2012
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT01602523
Brief Title
Effect of Symbicort on Sleep Quality in Patients With Emphysema
Official Title
Effect of Symbicort on Sleep Quality in Patients With Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Poor Sleep Quality
Keywords
Emphysema, COPD, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
budesonide/formoterol
Arm Type
Active Comparator
Arm Description
budesonide/formoterol 160/4.5 mcg (Symbicort)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Symbicort placebo
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol
Other Intervention Name(s)
Symbicort
Intervention Description
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo inhaler once daily 28 days
Primary Outcome Measure Information:
Title
The primary outcome is the objective assessment of sleep quality.
Description
Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Secondary outcome includes assessment of nocturnal oxygenation.
Description
Nocturnal oxygenation will be measured by pulse oximetry.
Time Frame
28 days
Title
Secondary outcome is the subjective assessment of sleep quality.
Description
Quality of life will be assessed by SF-36 and SGRQ-C scores.
Time Frame
28 days
Title
Secondary outcome includes assessment respiratory mechanics/function.
Description
Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
Time Frame
28 days
Title
Secondary outcome includes assessment of overall quality of life.
Description
Quality of life will be assessed by SF(short form)-36 and SGRQ-C(ST George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease patients)scores.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe emphysema (GOLD stages 2 and 3) Exclusion Criteria: Use of supplemental oxygen, A recent COPD exacerbation within the past 4 weeks. A previous diagnosis of obstructive sleep apnea A known urinary outflow obstruction, Glaucoma History of an allergic reaction to one of the study medications.
Facility Information:
Facility Name
Temple Lung Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

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Effect of Symbicort on Sleep Quality in Patients With Emphysema

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